Multi-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.

Comparison between diagnoses made from viewing microscopes v. digital imaging to support Philips’ de novo submission to the U.S. Food and Drug Administration

Multicenter study is one of the largest investigations assessing viability of digital pathology for primary diagnostic use

October 21, 2016

Amsterdam, The Netherlands ––Royal Philips (NYSE: PHG, AEX: PHIA) today announced the successful completion of its well-controlled, multicenter pivotal validation study designed to compare diagnoses determined by pathologists from digital whole slide imaging to traditional optical diagnoses through a microscope. The study, which examined the viewing, reviewing and diagnosing of surgical pathology tissue slides from a range of tissues met its pre-specified endpoint.

In the US, the Philips IntelliSite Digital Pathology Solution is presently cleared as an aid to the pathologist in the detection of HER2/neu. The newly completed clinical validation study by Philips will be submitted to FDA, with other data and information, in support of a de novo submission that, if cleared by FDA, would result in expanded indications for use.

“Philips is committed to working alongside regulators and pathologists to better understand and evaluate the clinical validity of this technology,” said Russell Granzow, General Manager, Philips Digital Pathology Solutions. “I wish to thank our clinical partner sites for their diligence during this seminal study.”

In one of the largest studies ever conducted to directly compare the use of digital pathology to optical microscopes, 16 pathologists at four clinical study sites – Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates – conducted approximately 16,000 reads across 2,000 cases.

The Non-inferiority study was designed to evaluate the difference in major discordance rates between diagnoses made with digital pathology or microscope. To measure this, the study had pathologists read slides obtained from cases at least one year old for which a main diagnosis was available. With this existing diagnosis serving as the point of comparison, pathologists then read and diagnosed each case both digitally and optically with a washout period of four weeks in between. The pre-specified endpoint for the primary analysis of this study was set on a maximum of four percent difference in major discordance rates. This study endpoint was successfully achieved the acceptance criterion with a final discordance rate of outcome of the study being only one percent.

“Pathology is a subjective field that is dependent on how the eye of each pathologist views what appears in the microscope. Defining how to measure and assess just how this process compares to a digital reading is complex,” said Dr. Clive Taylor, the principal investigator. “The design of this study holds the original diagnosis to be the truth and that provides us with a base to compare all readings by all pathologists in the study.”

“Proving that digital reads are not inferior to optical reads creates a foundation for a FDA submission that, if cleared, would allow for the shift to a digital operation that, in turn, may reap the additional benefits of collaboration, workflow efficiency and the use of precise tools for measurement and counting,” adds Dr. Michael Feldman.

* In the European Union, the Philips IntelliSite Pathology Solution is CE Marked under the European Union's 'In Vitro Diagnostics Directive' for in vitro diagnostic use. In Canada, the Philips IntelliSite Pathology Solution is licensed by Health Canada for in vitro diagnostic use. In the United States, the Philips IntelliSite Pathology Solution is indicated for in vitro diagnostic use for Manual Read of the Digital HER2 Application. The Philips IntelliSite Pathology Solution is registered for in vitro diagnostic use in Australia, New Zealand, Singapore and Middle East.

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Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Headquartered in the Netherlands, Philips' health technology portfolio generated 2015 sales of EUR 16.8 billion and employs approximately 69,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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